Additional Materials:

Contact:

Every year, some meat and poultry products are contaminated with microbial pathogens--such as Salmonella and E. coli--that cause foodborne illnesses and deaths. To improve the safety of meat and poultry products, the U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) introduced additional regulatory requirements for meat and poultry plants. These requirements are intended to ensure that plants operate food safety systems that are prevention-oriented and science-based. These systems, called Hazard Analysis and Critical Control Point (HACCP) systems, were phased in from January 1998 through January 2000 at all meat and poultry slaughter and processing plants. As the foundation of the HACCP system, plants are responsible for developing HACCP plans that, among other things, identify all of the contamination hazards that are reasonably likely to occur in a plant's particular production environment, establish all of the necessary steps to control these hazards, and have valid scientific evidence to support their decisions. GAO found that FSIS is not ensuring that all plants' HACCP plans meet regulatory requirements. As a result, consumers may be unnecessarily exposed to unsafe foods that can cause foodborne illnesses. In particular, FSIS's inspectors have not consistently identified and documented failures of plants' HACCP plans to comply with requirements. In addition, although sound science is the cornerstone of an effective HACCP plan, FSIS does not expect its inspectors to determine whether HACCP plans are based on sound science because inspectors lack the expertise to do so. FSIS is not consistently identifying repetitive violations, according to GAO's review of 1,180 noncompliance records for fiscal year 2001. This has occurred, in part, because FSIS has not established specific, uniform, and clearly defined criteria for its inspectors to use in determining when a violation is repetitive. Furthermore, at the district level, FSIS officials' understanding of the criteria to consider in determining if a violation is repetitive varied. Also, in several instances, inspectors have not fully documented the basis for their decisions about repetitive violations on noncompliance records. FSIS is not ensuring that plants take prompt and effective action to return to compliance after a HACCP violation has been identified. The longer that FSIS allows plants to remain out of compliance with regulatory requirements, the greater the risk that unsafe food will be produced and marketed.

Recommendations for Executive Action

Status: Closed - Implemented

Comments: USDA's FSIS provided extensive training to all inspection program personnel in sanitation procedures and HACCP system principles, which included training on how to make effective regulatory decisions, document noncompliance and initiate enforcement actions when warranted. FSIS sought and Congress provided the additional funding to support the expanded training and education.

Recommendation: To ensure that all HACCP plans fully meet regulatory requirements, the Secretary of Agriculture should direct FSIS to provide inspectors with additional training on their roles and responsibilities under the HACCP system and use data, such as the results from the food safety system correlation reviews, to help target training to address specific weaknesses.

Agency Affected: Department of Agriculture

Status: Closed - Implemented

Comments: The Food Safety and Inspection Service implemented its In-Plant Performance System (IPPS), which requires that each field supervisor annually conduct at least three on-site reviews of employees' job performance. FSIS also developed supervisory guidelines as part of the IPPS to help supervisors assess whether inspectors are consistently and uniformly implementing their responsibilities.

Recommendation: To ensure that all HACCP plans fully meet regulatory requirements, the Secretary of Agriculture should direct FSIS to develop procedures for its field supervisors and district managers to use to monitor inspector activities, including, among other things, ensuring that FSIS inspectors are consistently applying HACCP requirements.

Agency Affected: Department of Agriculture

Status: Closed - Implemented

Comments: FSIS implemented a risk-based strategy that included using Consumer Safety Officers to conduct comprehensive assessments of HACCP plans at all large raw product establishments, which FSIS identified as presenting higher risk of causing illnesses. FSIS plans to expand this to smaller establishments in the future. In addition, FSIS' strategy targets in-depth HACCP and sanitation reviews of any establishments that display negative performance trends in Salmonella testing. FSIS cites the break in the annual cycle of multi-million pound recalls as an indicator of the progress of its risk-based approach.

Recommendation: To ensure that all HACCP plans fully meet regulatory requirements, the Secretary of Agriculture should direct FSIS to develop a risk-based strategy and time frames for consumer safety officers to complete their reviews of HACCP plans at all plants.

Agency Affected: Department of Agriculture

Status: Closed - Implemented

Comments: FSIS sought and received funds to develop and upgrade information technology systems. With that improved data infrastructure, FSIS initiated a strategy that uses, among other things, enhanced data integration to anticipate and predict food safety risks. FSIS is using the system to combine regulatory sampling data and other data, including baseline studies, to detect trends and identify connections between persistence, prevalence, and plant size. With FSIS' geographically dispersed workforce, databases that communicate inspection information accurately and quickly should help managers in the field and at headquarters make crucial decisions and take timely actions.

Recommendation: To ensure that all HACCP plans fully meet regulatory requirements, the Secretary of Agriculture should direct FSIS to develop a strategy for its supervisors, managers, and officials to systematically use data, including annual data on noncompliance records by districts, to help oversee plants' compliance with HACCP requirements.

Agency Affected: Department of Agriculture

Status: Closed - Implemented

Comments: In October 2005, FSIS issued detailed instructions entitled: HACCP for Raw Processes -- Decision-making, Documentation, and Enforcement. It provides, among other things, step-by-step direction at a level of detail intended to guide the decision-making thought process to determine whether or not an establishment has repetitive instances of noncompliance. FSIS cites variances in plants processes for not setting specific numeric criteria. However, the instructions require a thorough analysis when one or more noncompliance reports have the same noncompliance classification indicators and problem descriptions, and a decision as to whether there may be a trend indicating the HACCP system is inadequate.

Recommendation: To ensure that FSIS inspectors and district officials use consistent criteria for identifying violations of HACCP regulatory requirements, the Secretary of Agriculture should direct FSIS to establish specific, uniform criteria for identifying repetitive violations.

Agency Affected: Department of Agriculture

Status: Closed - Implemented

Comments: FSIS's recently revised instructions direct inspectors to thoroughly document observed noncompliance. They further direct inspectors and decision-makers to thoroughly analyze and document every instance when two or more noncompliance reports from a facility have the same noncompliance classification indicators and the descriptions indicate a similar problem, for trends indicating that a plant's HACCP system is inadequate. Although it does not set a specific number of times a type of problem would have to occur to constitute a trend, the directed focus on repetitive noncompliance achieves the intent of our recommendation

Recommendation: To ensure that FSIS inspectors and district officials use consistent criteria for identifying repetitive violations of HACCP regulatory requirements, the Secretary of Agriculture should direct FSIS to ensure that inspectors consistently document repetitive violations.

Agency Affected: Department of Agriculture

Status: Closed - Implemented

Comments: Training for inspection personnel on current HACCP system principles emphasizes the importance of identifying trends that may indicate an inadequate HACCP system, and the revised inspection guidance describes the analysis and documentation process for identifying and linking repetitive violations in a plant. Finally, FSIS's recently implemented integrated data systems facilitate identifying and linking instances of repetitive violations at plants.

Recommendation: To ensure that FSIS inspectors and district officials use consistent criteria for identifying repetitive violations of HACCP regulatory requirements, the Secretary of Agriculture should direct FSIS to modify data management systems to capture the extent to which inspectors are identifying repetitive violations at plants.

Agency Affected: Department of Agriculture

Status: Closed - Implemented

Comments: FSIS has revamped, revised, and integrated data systems to provide field and headquarters supervisors and managers with information resources to facilitate oversight, management, and decision-making. Training has been provided on what the systems can provide and how to use the data. Detailed and summary trend data from HACCP inspections is included.

Recommendation: To ensure that FSIS inspectors and district officials use consistent criteria for identifying repetitive violations of HACCP regulatory requirements, the Secretary of Agriculture should direct FSIS to develop a strategy for its supervisors, managers, and officials to systematically use available data, including summary information, to help identify repetitive violations.

Agency Affected: Department of Agriculture

Status: Closed - Implemented

Comments: FSIS issued instructions for inspectors to analyze and document violations that are similar and may indicate an inadequate HACCP system.

Recommendation: To ensure that plants take prompt actions to correct violations, the Secretary of Agriculture should direct FSIS to establish clear, consistent criteria for inspectors to use when considering whether to recommend suspension because of repetitive violations.

Agency Affected: Department of Agriculture

Status: Closed - Implemented

Comments: Revised FSIS instruction to inspectors requires them to document their decisions and whether further enforcement is indicated based on a determination of repetitive violations that indicate a trend, which would indicate an inadequate HACCP system.

Recommendation: To ensure that plants take prompt actions to correct violations, the Secretary of Agriculture should direct FSIS to require its inspectors to document the basis for their decision on whether or not to recommend further enforcement action based upon documented repetitive violations.

Agency Affected: Department of Agriculture

Status: Closed - Implemented

Comments: New FSIS procedures for using salmonella performance standards allow in-depth review of a plant's sanitation. HACCP will be initiated after the plant fails to meet the standards in any series of tests, no longer requiring FSIS to wait for two consecutive failures.

Recommendation: To ensure that plants take prompt actions to correct violations, the Secretary of Agriculture should direct FSIS to develop guidance with specific time frames for actions to be taken at plants that fail a second set of Salmonella tests, including time frames for FSIS to initiate an in-depth verification review, report the results of the review, and initiate a third set of tests.

Agency Affected: Department of Agriculture

Status: Closed - Implemented

Comments: FSIS created an Office of Program Evaluation, Enforcement, and Review (OPEER) to modernize the agency's enforcement activities. OPEER is using newly established methodologies and protocols to enhance inspection and enforcement activities and a new internal audit process to head off problems that could result from corrective enforcement action. The actions OPEER is taking address the intent of our recommendation.

Recommendation: To ensure that plants take prompt actions to correct violations, the Secretary of Agriculture should direct FSIS to establish, and document in enforcement case files, time frames for plants with suspensions in abeyance to implement and verify the necessary corrective actions.

Agency Affected: Department of Agriculture

Status: Closed - Implemented

Comments: OPEER, recently formed by FSIS, is taking actions that address the intent of our recommendation.

Recommendation: To ensure that plants take prompt actions to correct violations, the Secretary of Agriculture should direct FSIS to document in the enforcement case file how and when the district office determined that the plant had completed its corrective actions and, if the suspension is allowed to remain in abeyance for more than 90 days, the reason for the extension.